Oseltamivir and Baloxavir Marboxil for Prophylaxis Against Influenza Under a Hospital-based Setting

A Randomized, Open-Label Clinical Study on the Efficacy of Baloxavir Marboxil and Oseltamivir for Post-Exposure Prevention of Influenza in a Hospital Setting

This study aims to randomly assign close contacts of hospitalized influenza virus patients to receive baloxavir marboxil prophylaxis, oseltamivir prophylaxis or no antiviral prophylaxis and monitor the incidence of clinical influenza, evaluating the prophylaxis efficiency of antivirals in a hospital setting.

Study Overview

• Status: Not yet recruiting
• Conditions: Influenza; Nosocomial Infection; Influenza Prophylaxis
• Intervention / Treatment: Drug: Baloxavir Marboxil; Drug: Oseltamivir

Detailed Description

This study will enroll hospitalized patients diagnosed with influenza virus infection (index patients) and their roommates who are not infected with the influenza virus (close contacts). The close contacts will be randomly assigned in a 1:1:1 ratio to receive baloxavir marboxil prophylaxis, oseltamivir prophylaxis or no antiviral prophylaxis. The incidence of clinical influenza (confirmed by reverse-transcriptase polymerase chain reaction (RT-PCR) testing, along with fever and one respiratory symptom) will be monitored to evaluate the efficiency of antiviral prophylaxis in a hospital setting. The index patients will receive standard treatment for influenza infection.

• Study Type: Interventional
• Enrollment (Estimated): 372
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yeming Wang, Ph.D.; Phone Number: +86 84206264; Email: wwyymm_love@163.com
• Study Contact Backup: Name: Ziyi Chu; Phone Number: +86 18168859689; Email: ziyichu123@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital
      • Contact: Bin Cao, Ph.D; Phone Number: 86 010 84206264; Email: caobin_ben@163.com
      • Contact: Yeming Wang, Ph.D; Email: wwyymm_love@163.com
      • Contact: Bin Cao, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Index patient:
• 1. Patients or accompanying caregivers hospitalized at participating medical institutions.
• 2.The subject and/or their legal guardian both agree to participate in this clinical study, sign the informed consent form, and are able to comply with the study requirements for follow-up and completion of all study procedures and assessments.
• 3.Age ≥ 2 years.
• 4.Influenza nucleic acid positivity confirmed by throat swab, sputum and other respiratory sample through rapid antigen testing (RAT) or PCR.
• Close contact:
• 1.Patients or accompanying caregivers hospitalized at participating medical institutions.
• 2.The subject and/or their legal guardian both agree to participate in this clinical study, sign the informed consent form, and are able to comply with the study requirements for follow-up and complete all study procedures and assessments
• 3.Age ≥ 12 years.
• 4.Expected to remain hospitalized for ≥ 72 hours.
• 5.The room must contain at least one hospitalized index patient diagnosed with influenza virus within the past 72 hours, and the contact is expected to stay with the hospitalized index patient in the ward for more than 24 hours.
• 6.Throat swab on the first day tested negative for influenza virus by PCR.

Exclusion Criteria:

• Close contacts
• 1.With known allergies to the active ingredients or excipients of the investigational drug.
• 2.Close contacts diagnosed with or having experienced an influenza virus infection within the past 12 weeks.
• 3.Close contacts who have used antiviral drugs (including neuraminidase inhibitors, hemagglutinin inhibitors, and M2 ion channel blockers, such as oseltamivir, zanamivir, peramivir, favipiravir, abidol, baloxavir marboxil, amantadine, rimantadine, or any other antiviral drugs approved by NMPA) within the 2 weeks prior to screening.
• 4.Close contacts known to be pregnant or breastfeeding.
• 5. Having experienced fever (axillary temperature ≥37.3°C) in the past 3 days prior to screening.
• 6.Subjects deemed unsuitable to participate in the study by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baloxavir Marboxil; Baloxavir marboxil will be administered on the first day following the close contact's enrollment in this study. Participants weighing ≤80 kg will receive 40 mg of baloxavir marboxil, while those weighing ≥80 kg will receive 80 mg.	Drug: Baloxavir Marboxil; Baloxavir marboxil will be administered on the first day following the close contact's enrollment in this study. Participants weighing ≤80 kg will receive 40 mg of baloxavir marboxil, while those weighing ≥80 kg will receive 80 mg.
Experimental: Oseltamivir Arm; Oseltamivir will be administered once daily for 5 consecutive days following the close contact's enrollment in this study. Participants will receive 75 mg of oseltamivir once each day	Drug: Oseltamivir; Oseltamivir will be administered once daily for 5 consecutive days following the close contact's enrollment in this study. Participants will receive 75 mg of oseltamivir once each day.
No Intervention: Control Arm; No antivirals will be administered to the contacts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Clinical Influenza within a 5-day period	Incidence of Clinical Influenza within a 5-day period is defined as the percentage of contacts who become positive for influenza based on reverse-transcriptase polymerase chain reaction (RT-PCR) testing or rapid antigen testing (RAT), along with fever (defined as axillary temperature ≥37.3℃) and at least one respiratory symptom.	up to 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of influenza within a 5-day period	Incidence of Influenza within a 5-day period is defined as the percentage of contacts who become positive for influenza based on reverse-transcriptase polymerase chain reaction (RT-PCR) testing or rapid antigen testing (RAT).	up to 5 days
Incidence of Clinical Influenza within a 10-day period	Incidence of Clinical Influenza within a 10-day period is defined as the percentage of contacts who become positive for influenza based on reverse-transcriptase polymerase chain reaction (RT-PCR) testing or rapid antigen testing (RAT), along with fever (defined as axillary temperature ≥37.3℃) and at least one respiratory symptom.	up to 10 days
Susceptibility to antivirals by phenotyping post-baseline samples with novel mutation	Susceptibility to antivirals by phenotyping post-baseline samples with novel mutation is defined as the percentage of contacts infected with resistance-associated treatment-emergent influenza variants.	up to 10 days

Collaborators and Investigators

• Sponsor: Capital Medical University
• Collaborators: China-Japan Friendship Hospital; Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Bin Cao, Ph.D, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 5, 2025
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): May 5, 2025

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: influenza; oseltamivir; nosocomial infection; baloxavir marboxil; influenza prophylaxis
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Influenza, Human; Cross Infection; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antiviral Agents; Baloxavir; Oseltamivir
• Other Study ID Numbers: 2024-KY-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No